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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/NCT06049095




Registration number
NCT06049095
Ethics application status
Date submitted
15/09/2023
Date registered
21/09/2023
Date last updated
28/12/2023

Titles & IDs
Public title
A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants
Scientific title
A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age
Secondary ID [1] 0 0
LTG-001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LTG-001
Treatment: Drugs - Placebo

Experimental: LTG-001 - Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts

Placebo Comparator: Placebo - Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts


Treatment: Drugs: LTG-001
Oral doses

Treatment: Drugs: Placebo
Oral doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects
Timepoint [1] 0 0
Up to 10 days of dosing
Secondary outcome [1] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [1] 0 0
Up to 10 days of dosing
Secondary outcome [2] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [2] 0 0
Up to 10 days of dosing
Secondary outcome [3] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [3] 0 0
Up to 10 days of dosing
Secondary outcome [4] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [4] 0 0
Up to 10 days of dosing
Secondary outcome [5] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [5] 0 0
Up to 10 days of dosing
Secondary outcome [6] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [6] 0 0
Up to 10 days of dosing
Secondary outcome [7] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [7] 0 0
Up to 10 days of dosing
Secondary outcome [8] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [8] 0 0
Up to 10 days of dosing
Secondary outcome [9] 0 0
To further characterize the PK of LTG-001 in healthy participants
Timepoint [9] 0 0
Up to 10 days of dosing

Eligibility
Key inclusion criteria
- Male and female participants aged 18 to 55 years, inclusive, at the time of signing
the informed consent.

- Overtly healthy with no clinically relevant abnormalities based on the medical
history, physical examinations, clinical laboratory evaluations, and 12-lead ECG that,
in the opinion of the investigator, would affect participant safety.

- Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Inability to take oral medications or gastrointestinal abnormalities potentially
impacting absorption

- Clinically significant cardiovascular, hematological, renal, hepatic, pulmonary,
endocrine, gastrointestinal, immunological, dermatological, neurological, or
psychiatric disease which could interfere with, or the treatment for which might
interfere with, the conduct of the study or which would, in the opinion of the
investigator, unacceptably increase the participant's risk by participating in the
study

- Past or current history or evidence of alcohol abuse and/or dependence on recreational
drug use

- Donation of over 500 mL blood = 3 months prior to start of participation

- Has known psychiatric disorders that would interfere with the cooperation with the
requirements of the study

- Participant is under legal custodianship.

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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Latigo Biotherapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and
multiple (MAD) ascending dose study to evaluate the safety, tolerability, and
pharmacokinetics (PK) of orally administered LTG-001 in healthy male and female participants
Trial website
https://clinicaltrials.gov/ct2/show/NCT06049095
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Desmond Padhi
Address 0 0
Country 0 0
Phone 0 0
8057162936
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06049095