A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants

Last updated: October 23, 2024
Sponsor: Latigo Biotherapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Placebo

LTG-001

Clinical Study ID

NCT06049095
LTG-001-001
  • 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) of orally administered LTG-001 in healthy male and female participants

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female participants aged 18 to 55 years, inclusive, at the time of signingthe informed consent.

  • 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:

  • Inability to take oral medications or gastrointestinal abnormalities potentiallyimpacting absorption

  • 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

  • Has known psychiatric disorders that would interfere with the cooperation with therequirements of the study

  • Participant is under legal custodianship.

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 17, 2023
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • Clinical Research Unit

    Christchurch,
    New Zealand

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.