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

NCT ID: NCT06049095

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2026-04-28

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) of orally or intravenously administered LTG-001 in healthy male and female participants

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LTG-001

Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts

Group Type: EXPERIMENTAL

LTG-001

Intervention Type: DRUG

Oral doses

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral doses

Interventions

LTG-001

Oral doses

Intervention Type: DRUG

Placebo

Oral doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption
• 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
• Has known psychiatric disorders that would interfere with the cooperation with the requirements of the study
• Participant is under legal custodianship.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Latigo Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Unit

Christchurch, , New Zealand

Site Status: RECRUITING

Countries

New Zealand

Central Contacts

Desmond Padhi

Role: CONTACT

LTG-001-001@latigobio.com

8057162936

Facility Contacts

Chris Wynne, MD

Role: primary

Chris.Wynne@nzcr.co.nz

+ 64 3 372 9477

Other Identifiers

LTG-001-001

Identifier Type: -

Identifier Source: org_study_id