HealthyPhase 1NCT06049095
A Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally in Healthy Participants
A Phase 1 study testing LTG-001 in people with Healthy, run by Latigo Biotherapeutics at 1 site in New Zealand.
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 or intravenously administered LTG-001 in healthy male and female participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LTG-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 Oct 2023to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age
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
- Conditions
- Healthy
- Being tested
- LTG-001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTG-001Drug
Oral doses
PlaceboDrug
Oral doses
| Study group | Role | What they receive |
|---|---|---|
| LTG-001 | Experimental | Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts Receives: Drug: LTG-001 |
| Placebo | Placebo comparator | Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 10 days of dosing
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.
Measured: from admission to completion in the study (35 days)
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.
Measured: From first intravenous dose through end of study (up to 14 days following intravenous dosing)
Secondary outcomes (9)
To further characterize the PK of LTG-001 in healthy participants
Cmax
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Area under the concentration curve from 0 to last (AUC0-last)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Area under the concentration curve from 0 to infinity (AUC0-inf)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time of the maximum observed plasma concentration (tmax)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Elimination rate constant (λz)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Terminal elimination half-life (t1⁄2)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Concentration at 12 hours (C12)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Oral clearance (CL/F)
Measured: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Oral apparent volume of distribution (Vz/F)
Measured: Up to 10 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Oct 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Latigo Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049095
- Sponsor's protocol ID
- LTG-001-001
- Status last verified
- Jun 2026
- First submitted
- 15 Sep 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally of Intravenously to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age
- ClinicalTrials.gov ID
- NCT06049095
- Acronym / sponsor ID
- LTG-001-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Latigo BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTG-001 | Experimental | Drug: LTG-001Part A: Single-Ascending dose cohorts; relative bioavailability; food effect; Part B: Multiple-ascending dose cohorts |
| Placebo | Placebo comparator | Drug: PlaceboPart A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTG-001Oral doses | Drug | LTG-001 |
| PlaceboOral doses | Drug | Placebo |
Primary outcome
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
To further characterize the PK of LTG-001 in healthy participants
Time frame: Up to 10 days of dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LTG-001 in people with Healthy, run by Latigo Biotherapeutics at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of single and multiple ascending oral doses, relative bioavailability and food effect of LTG-001 in healthy subjects (time frame: Up to 10 days of dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.