Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06049095

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Unit

Christchurch, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LTG-001

Drug

Oral doses

Placebo

Drug

Oral doses

Primary outcomes

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

    Time frame: Up to 10 days of dosing

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

  2. Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration

    Time frame: from admission to completion in the study (35 days)

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

  3. Safety and Tolerability of Intravenous LTG-001

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

    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.

Secondary outcomes

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

    Time frame: Up to 10 days of dosing

    Cmax

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

    Time frame: Up to 10 days of dosing

    Area under the concentration curve from 0 to last (AUC0-last)

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

    Time frame: Up to 10 days of dosing

    Area under the concentration curve from 0 to infinity (AUC0-inf)

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

    Time frame: Up to 10 days of dosing

    Time of the maximum observed plasma concentration (tmax)

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

    Time frame: Up to 10 days of dosing

    Elimination rate constant (λz)

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

    Time frame: Up to 10 days of dosing

    Terminal elimination half-life (t1⁄2)

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

    Time frame: Up to 10 days of dosing

    Concentration at 12 hours (C12)

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

    Time frame: Up to 10 days of dosing

    Oral clearance (CL/F)

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

    Time frame: Up to 10 days of dosing

    Oral apparent volume of distribution (Vz/F)

Sponsors and collaborators

Lead sponsor

Latigo Biotherapeutics

Industry

Registry information

Official study title

A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.