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

NCT06554574 | Completed Phase 1

• 1 other identifier: LTG-305-001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of single and multiple ascending oral doses of LTG-305 in healthy participants.

  Incidence, severity, seriousness, and causality of treatment-emergent adverse events (TEAEs)

  Up to 7 or 10 days of dosing

• To evaluate the pharmacodynamics of LTG-305 in healthy male participants.

  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

  0-24 hrs, 1-12 hours

Study Arms (2)

LTG-305

EXPERIMENTAL

Drug: LTG-305

Placebo

PLACEBO COMPARATOR

Drug: LTG-305

Interventions

LTG-305 DRUG

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

LTG-305; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Latigo Biotherapeutics: lead

Study Sites (1)

Clinical Research Unit

Christchurch, New Zealand

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: September 3, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)