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

NCT06049095 | Recruiting Phase 1

• 1 other identifier: LTG-001-001
• Study Type: interventional
• Target: 204
• 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) of orally or intravenously administered LTG-001 in healthy male and female participants

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects

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

  Up to 10 days of dosing

• Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration

  Absolute bioavailability of LTG-001 will be assessed by comparing systemic exposure following a single oral tablet dose and a single intravenous dose.

  from admission to completion in the study (35 days)

• Safety and Tolerability of Intravenous LTG-001

  Safety and tolerability of intravenous LTG-001 will be assessed by the number of participants with treatment-emergent adverse events (TEAEs), changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), physical examination findings, and infusion site reactions following intravenous administration.

  From first intravenous dose through end of study (up to 14 days following intravenous dosing)

Secondary Outcomes (9)

• To further characterize the PK of LTG-001 in healthy participants

  Up to 10 days of dosing

• To further characterize the PK of LTG-001 in healthy participants

  Up to 10 days of dosing

• To further characterize the PK of LTG-001 in healthy participants

  Up to 10 days of dosing

• To further characterize the PK of LTG-001 in healthy participants

  Up to 10 days of dosing

• To further characterize the PK of LTG-001 in healthy participants

  Up to 10 days of dosing

Study Arms (2)

LTG-001

EXPERIMENTAL

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

Drug: LTG-001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LTG-001 DRUG

Oral doses

LTG-001

Placebo DRUG

Oral doses

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.
• 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:

• 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.

Sponsors & Collaborators

• Latigo Biotherapeutics: lead

Study Sites (1)

Clinical Research Unit

Christchurch, New Zealand

RECRUITING

Central Study Contacts

Desmond Padhi

CONTACT

8057162936; LTG-001-001@latigobio.com

Study Design

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

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: October 17, 2023
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)