A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: LTG-305

• Registration Number: NCT06554574
• Lead Sponsor: Latigo Biotherapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-15
• Study Start: 2024-09-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-08-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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).

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	LTG-305	-
LTG-305	LTG-305	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.	Up to 7 or 10 days of dosing	Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)
To evaluate the pharmacodynamics of LTG-305 in healthy male participants.	0-24 hrs, 1-12 hours	Change from baseline at various individual time points and at various intervals for time to reach PDT and time to reach PTT, for each dose of LTG-305 vs. placebo.; Time to reach PDT and time to reach PTT at various individual time points and at various intervals for each dose of LTG-305 vs. placebo.; Area above the Curve (AAC) calculated via NPRS scores vs. time, for each dose of LTG-305 vs. placebo Exposure response

Trial Locations

Locations (1)

Clinical Research Unit; 🇳🇿 Christchurch, New Zealand