Healthy
Conditions
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
Interventions
DRUGLTG-001
Oral doses
DRUGPlacebo
Oral doses
Sponsors
Latigo Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Absolute Bioavailability of LTG-001 Following Oral and Intravenous Administration | 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. |
| Safety and Tolerability of Intravenous LTG-001 | 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
| Measure | Time frame | Description |
|---|---|---|
| To further characterize the PK of LTG-001 in healthy participants | Up to 10 days of dosing | Cmax |
Countries
New Zealand
Outcome results
None listed