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

• Sponsor: Latigo Biotherapeutics (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06049095
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 12

Study Details

Study Description

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 administered LTG-001 in healthy male and female participants

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LTG-001; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: May 31, 2024
• Anticipated Study Completion Date: May 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LTG-001 Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts	Drug: LTG-001; Oral doses
Placebo Comparator: Placebo Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts	Drug: Placebo; Oral doses

Outcome Measures

Primary Outcome Measures

1. Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects [Up to 10 days of dosing]

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

Secondary Outcome Measures

1. To further characterize the PK of LTG-001 in healthy participants [Up to 10 days of dosing]

   Cmax

2. To further characterize the PK of LTG-001 in healthy participants [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 [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 [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 [Up to 10 days of dosing]

   Elimination rate constant (λz)

6. To further characterize the PK of LTG-001 in healthy participants [Up to 10 days of dosing]

   Terminal elimination half-life (t1⁄2)

7. To further characterize the PK of LTG-001 in healthy participants [Up to 10 days of dosing]

   Concentration at 12 hours (C12)

8. To further characterize the PK of LTG-001 in healthy participants [Up to 10 days of dosing]

   Oral clearance (CL/F)

9. To further characterize the PK of LTG-001 in healthy participants [Up to 10 days of dosing]

   Oral apparent volume of distribution (Vz/F)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Unit	Christchurch		New Zealand

Sponsors and Collaborators

• Latigo Biotherapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Latigo Biotherapeutics
• ClinicalTrials.gov Identifier: NCT06049095
• Other Study ID Numbers: LTG-001-001
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 25, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 25, 2023