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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01776528
Registration number
NCT01776528
Ethics application status
Date submitted
18/01/2013
Date registered
28/01/2013
Date last updated
31/12/2013
Titles & IDs
Public title
Phase 1 SAD and MAD Study of NGM282 in Healthy Adult Participants
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Scientific title
A Phase 1 Randomized, Double Blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NGM282 in Healthy Adult Participants
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Secondary ID [1]
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12-0101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - NGM282
Other interventions - Placebo
Experimental: Cohort 1 SAD - NGM282 Dose 1 vs Placebo
Experimental: Cohort 2 SAD - NGM282 Dose 2 vs Placebo
Experimental: Cohort 3 SAD - NGM282 Dose 3 vs Placebo
Experimental: Cohort 4 SAD - NGM282 Dose 4 vs Placebo
Experimental: Cohort 5 SAD - NGM282 Dose 5 vs Placebo
Experimental: Cohort 6 SAD - NGM282 Dose 6 vs Placebo
Experimental: Cohort 7 MAD - NGM282 Dose 1 vs Placebo
Experimental: Cohort 8 MAD - NGM282 Dose 2 vs Placebo
Experimental: Cohort 9 MAD - NGM282 Dose 3 vs Placebo
Experimental: Cohort 10 MAD - NGM282 Dose 4 vs Placebo
Experimental: Cohort 11 MAD - NGM282 Dose 5 vs Placebo
Experimental: Cohort 12 MAD - NGM282 Dose 6 vs Placebo
Other interventions: NGM282
Other interventions: Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and tolerability
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Assessment method [1]
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To evaluate the safety and tolerability of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
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Timepoint [1]
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7 days and 14 days
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Secondary outcome [1]
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Pharmacokinetics
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Assessment method [1]
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To evaluate the pharmacokinetics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
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Timepoint [1]
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7 days and 14 days
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Secondary outcome [2]
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Pharmacodynamics
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Assessment method [2]
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To evaluate the pharmacodynamics of single ascending doses and multiple ascending doses of NGM282 in healthy adult participants.
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Timepoint [2]
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7 days and 14 days
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Eligibility
Key inclusion criteria
- Males or females, between 18 and 65 years of age, inclusive
- BMI range is 20-35 kg/m2, inclusive for the SAD Module, and 25-35 kg/m2, inclusive for
the MAD Module at Screening;
- In good health, determined by no clinically significant findings from medical history,
physical exam, 12 lead ECG, clinical laboratory findings, and vital signs at Screening
and Day -1
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Significant history or clinical manifestation of any significant metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, GI,
neurological, or psychiatric disorder (as determined by the PI)
- History of significant hypersensitivity, intolerance, or allergy to any drug compound,
food, or other substance
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2013
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Sample size
Target
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Accrual to date
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Final
119
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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NGM Clinical Study Site - Perth
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Recruitment postcode(s) [1]
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6009 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
NGM Biopharmaceuticals, Inc
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the safety and tolerability of NGM282, both single
dose and multiple doses, in normal healthy adult participants.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01776528
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Alex M DePaoli, MD
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Address
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NGM Biopharmaceuticals, Inc
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01776528
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