Clinical trial NCT06049095: A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Latigo Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects
timeFrame: Up to 10 days of dosing
Secondary outcomes:
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
measure: To further characterize the PK of LTG-001 in healthy participants
timeFrame: Up to 10 days of dosing
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Clinical Research Unit
Study officials:
References: