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NCT06554574 | RECRUITING | Healthy

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

Condition or disease

Healthy

Intervention/treatment

LTG-305

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official 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
Actual Study Start Date : 2024-09-03
Estimated Primary Completion Date : 2025-03-31
Estimated Study Completion Date : 2025-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants

Location Details

NCT06554574

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Locations

RECRUITING

New Zealand,

Clinical Research Unit

Christchurch, New Zealand,