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

Last updated: May 19, 2025
Sponsor: Latigo Biotherapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

LTG-305

Clinical Study ID

NCT06554574
LTG-305-001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants aged 18 to 55 years, inclusive, at the time of signingthe 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 medicalhistory, physical examinations, clinical laboratory evaluations, and 12-lead ECGthat, in the opinion of the investigator, would affect participant safety.

  • Body mass index (BMI) within the range of 18-32 kg/m2 (inclusive).

Exclusion

Exclusion Criteria:

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

  • Past or current history or evidence of alcohol abuse and/or dependence onrecreational drug use

  • Donation of over 500 mL blood ≤ 3 months prior to start of participation

  • Participant is under legal custodianship.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: LTG-305
Phase: 1
Study Start date:
September 03, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Clinical Research Unit

    Christchurch,
    New Zealand

    Active - Recruiting

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