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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/NCT04196179




Registration number
NCT04196179
Ethics application status
Date submitted
9/12/2019
Date registered
12/12/2019
Date last updated
21/07/2021

Titles & IDs
Public title
ANG-3070 in Healthy Adult Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of ANG-3070 in Healthy Adult Participants
Secondary ID [1] 0 0
ANG-3070-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ANG3070
Treatment: Drugs - Placebo oral capsule

Experimental: SAD - A1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral
A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral
A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral
Day 15 ANG-3070 200mg (n=6) / Placebo (n=2) Oral
A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral
A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) Oral
D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg *with and without food* (n=6)/ Placebo (n=2) Oral

Experimental: MAD - B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2)
B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2)
B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2)
B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2)
C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2)
C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2)


Treatment: Drugs: ANG3070
ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.

Treatment: Drugs: Placebo oral capsule
ANG-3070 placebo capsules visually match the drug product.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in Adverse Events
Timepoint [1] 0 0
Up to the Follow Up visit 8 days after the last study drug administration
Primary outcome [2] 0 0
Difference in Vital Signs
Timepoint [2] 0 0
Up to the Follow Up visit 8 days after the last study drug administration
Primary outcome [3] 0 0
Difference in Physical Exam
Timepoint [3] 0 0
Up to the Follow Up visit 8 days after the last study drug administration
Primary outcome [4] 0 0
Difference in Lab Values
Timepoint [4] 0 0
Up to the Follow Up visit 8 days after the last study drug administration
Primary outcome [5] 0 0
Difference in ECG QT interval
Timepoint [5] 0 0
Up to the Follow Up visit 8 days after the last study drug administration
Secondary outcome [1] 0 0
Assess PK
Timepoint [1] 0 0
Up to the Follow Up visit 8 days after the last study drug administration

Eligibility
Key inclusion criteria
1. Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of
informed consent);

2. Participants must be in good general health, with no significant medical history, have
no clinically significant abnormalities on physical examination at Screening and/or
before administration of the initial dose of study drug; and

3. Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI)
between =18.0 and =32.0 kg/m2 at Screening;
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
any time during the study, including the follow-up period;

2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory
abnormality that, in the Investigator's (or delegate's) opinion, could adversely
affect the safety of the participant;

3. History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis,
lactose intolerance, and Helicobacter (H.) pylori infection;

4. Presence of any underlying physical or psychological medical condition that, in the
opinion of the Investigator, would make it unlikely that the participant will comply
with the protocol or complete the study per protocol;

5. Any surgical or medical condition that could interfere with the absorption,
distribution, metabolism, or excretion of the study drug;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/03/2021
Sample size
Target
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network, VIC - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Angion Biomedica Corp
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food
effect of single and multiple ascending doses of ANG-3070 in healthy adult participants.

This study is comprised of 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple
ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each
cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6
subjects receiving active ANG-3070)
Trial website
https://clinicaltrials.gov/ct2/show/NCT04196179
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shakil Aslam, MD
Address 0 0
Angion Biomedica
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04196179