Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06554574




Registration number
NCT06554574
Ethics application status
Date submitted
12/08/2024
Date registered
15/08/2024
Date last updated
26/11/2024

Titles & IDs
Public title
A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants
Scientific title
A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-305 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age
Secondary ID [1] 0 0
LTG-305-001
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-305

Experimental: LTG-305 -

Placebo comparator: Placebo -


Treatment: Drugs: LTG-305
Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.
Timepoint [1] 0 0
Up to 7 or 10 days of dosing
Primary outcome [2] 0 0
To evaluate the pharmacodynamics of LTG-305 in healthy male participants.
Timepoint [2] 0 0
0-24 hrs, 1-12 hours

Eligibility
Key inclusion criteria
* Male and female participants aged 18 to 55 years, inclusive, at the time of signing the informed consent for SAD and MAD only. For Cold Pressor male participants 18 to 55 years.
* 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
* 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
* 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
Other
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
3/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
120
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) and Pharmacodynamics of orally administered LTG-305 in healthy male and female participants. The study will also include a randomized, double-blind, placebo-controlled within-participant crossover evaluation of pain tolerance during a cold pressor test in healthy male participants 18-55 years of age.
Trial website
https://clinicaltrials.gov/study/NCT06554574
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
Diamond Martin
Address 0 0
Country 0 0
Phone 0 0
818-309-3483
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/study/NCT06554574