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Active, not recruitingNCT06049095Updated Jun 16, 2026

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

A Phase 1 interventional study of LTG-001 and Placebo in Healthy, sponsored by Latigo Biotherapeutics. Active, not recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Latigo Biotherapeutics · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Latigo Biotherapeutics is the lead sponsor of 8 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
204 participants (estimated)

Study arms

  • Experimental
    LTG-001

    Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts

    Drug: LTG-001

  • Placebo comparator
    Placebo

    Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts

    Drug: Placebo

Interventions

  • DrugLTG-001

    Oral doses

  • DrugPlacebo

    Oral doses

06

What researchers measure

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

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

    Time frame: Up to 10 days of dosing

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

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

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

  3. Safety and Tolerability of Intravenous LTG-001

    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.

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

Secondary outcomes

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

    Cmax

    Time frame: Up to 10 days of dosing

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

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

    Time frame: Up to 10 days of dosing

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

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

    Time frame: Up to 10 days of dosing

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

    Time of the maximum observed plasma concentration (tmax)

    Time frame: Up to 10 days of dosing

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

    Elimination rate constant (λz)

    Time frame: Up to 10 days of dosing

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

    Terminal elimination half-life (t1⁄2)

    Time frame: Up to 10 days of dosing

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

    Concentration at 12 hours (C12)

    Time frame: Up to 10 days of dosing

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

    Oral clearance (CL/F)

    Time frame: Up to 10 days of dosing

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

    Oral apparent volume of distribution (Vz/F)

    Time frame: Up to 10 days of dosing

07

Study locations

1 site
  • Clinical Research Unit
    Christchurch, New Zealand
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06049095
Lead sponsor
Latigo Biotherapeutics
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Oct 17, 2023
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Jun 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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