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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049095
• Other study ID #: LTG-001-001
• Status: Recruiting
• Phase: Phase 1
• Start date: October 17, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Latigo Biotherapeutics
• Contact: Desmond Padhi
• Phone: 8057162936
• Email: LTG-001-001[@]latigobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LTG-001
Oral doses
• Placebo
Oral doses

Locations

Country	Name	City	State
New Zealand	Clinical Research Unit	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Latigo Biotherapeutics

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	To further characterize the PK of LTG-001 in healthy participants	Cmax	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Area under the concentration curve from 0 to last (AUC0-last)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Area under the concentration curve from 0 to infinity (AUC0-inf)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Time of the maximum observed plasma concentration (tmax)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Elimination rate constant (?z)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Terminal elimination half-life (t1/2)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Concentration at 12 hours (C12)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Oral clearance (CL/F)	Up to 10 days of dosing
Secondary	To further characterize the PK of LTG-001 in healthy participants	Oral apparent volume of distribution (Vz/F)	Up to 10 days of dosing