A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TESP-0401 in Healthy Participants

NCT07658638 | Recruiting Phase 1 DMC

• 1 other identifier: TESP-0401-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this intervention study is to evaluate the safety and tolerability of TESP-0401, and to understand how the body processes TESP-0401, in healthy participants after single and multiple doses. The study aims to answer the following questions: 1. What are the safety, tolerability, and pharmacokinetic characteristics of a single dose of TESP-0401 in healthy participants? 2. What are the safety, tolerability, and pharmacokinetic characteristics of multiple doses of TESP-0401 in healthy participants? This study will be a randomized, placebo controlled study.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of participants with SAEs, TEAEs, with abnormal clinical laboratory tests results, abnormal vital signs, abnormal ECG readings and abnormal physical examination findings

  up to 8 days after the last dose

Secondary Outcomes (7)

• Maximum concentration of the drug (Cmax) following single and multiple doses of TESP-0401 in healthy participants

  up to 9 days

• Time to peak concentration (Tmax) following single and multiple doses of TESP-0401 in healthy participants

  up to 9 days

• Clearance (CL) following single and multiple doses of TESP-0401 in healthy participants

  up to 9 days

• Elimination half-life (t1/2) following single and multiple doses of TESP-0401 in healthy participants

  up to 9 days

• Volume of distribution (Vd) following single and multiple doses of TESP-0401 in healthy participants.

  up to 9 days

Study Arms (20)

Part A SAD - Cohort 1

EXPERIMENTAL

IV, once, over 60 minutes, in a fasted state

Drug: TESP-0401

Part A SAD - Placebo Cohort 1

PLACEBO COMPARATOR

IV infusion of placebo, once, over 60 minutes, in a fasted state

Drug: Placebo

Part A SAD - Cohort 2

EXPERIMENTAL

IV, once, over 60 minutes, in a fasted state

Drug: TESP-0401

Part A SAD - Placebo Cohort 2

PLACEBO COMPARATOR

IV infusion of placebo, once, over 60 minutes, in a fasted state

Drug: Placebo

Part A SAD - Cohort 3

EXPERIMENTAL

IV, once, over 60 minutes, in a fasted state

Drug: TESP-0401

Part A SAD - Placebo Cohort 3

PLACEBO COMPARATOR

IV infusion of placebo, once, over 60 minutes, in a fasted state

Drug: Placebo

Part A SAD - Cohort 4

EXPERIMENTAL

IV, once, over 60 minutes, in a fasted state

Drug: TESP-0401

Part A SAD - Placebo Cohort 4

PLACEBO COMPARATOR

IV infusion of placebo, once, over 60 minutes, in afasted state

Drug: Placebo

Part A SAD - Cohort 5

EXPERIMENTAL

IV, once, over 60 minutes, in a fasted state

Drug: TESP-0401

Part A SAD - Placebo Cohort 5

PLACEBO COMPARATOR

IV infusion of placebo, once, over 60 minutes, in a fasted state

Drug: Placebo

Part A SAD - Cohort 6

EXPERIMENTAL

IV, once, over 60 minutes in a fasted state

Drug: TESP-0401

Part A SAD - Placebo Cohort 6

PLACEBO COMPARATOR

IV infusion of placebo, once, over 60 minutes, in a fasted state

Drug: Placebo

Part B MAD - Cohort 1

EXPERIMENTAL

IV infusion,QD for 7 days, over 60 minutes, ina fasted state

Drug: TESP-0401

Part B MAD - Placebo Cohort 1

PLACEBO COMPARATOR

IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state

Drug: Placebo

Part B MAD - Cohort 2

EXPERIMENTAL

IV infusion, QD for 7 days, over 60 minutes,in a fasted state

Drug: TESP-0401

Part B MAD - Placebo Cohort 2

PLACEBO COMPARATOR

IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state

Drug: Placebo

Part B MAD - Cohort 3

EXPERIMENTAL

IV infusion, QD for 7 days, over 60 minutes,in a fasted state

Drug: TESP-0401

Part B MAD - Placebo Cohort 3

PLACEBO COMPARATOR

IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state

Drug: Placebo

Part B MAD - Cohort 4

EXPERIMENTAL

IV infusion, QD for 7 days, over 60 minutes,in a fasted state

Drug: TESP-0401

Part B MAD - Placebo Cohort 4

PLACEBO COMPARATOR

IV infusion of placebo, QD for 7 days, over 60 minutes, in a fasted state

Drug: Placebo

Interventions

TESP-0401 DRUG

IV infusion, single administration, over 60 minutes, in a fasted state

Part A SAD - Cohort 1; Part A SAD - Cohort 2; Part A SAD - Cohort 3; Part A SAD - Cohort 4; Part A SAD - Cohort 5; Part A SAD - Cohort 6

Placebo DRUG

IV infusion of placebo, once, over 60 minutes, in a fasted state

Part A SAD - Placebo Cohort 1; Part A SAD - Placebo Cohort 2; Part A SAD - Placebo Cohort 3; Part A SAD - Placebo Cohort 4; Part A SAD - Placebo Cohort 5; Part A SAD - Placebo Cohort 6

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are healthy as determined no clinically significant findings by the PI/delegate in medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG.
• Systolic blood pressure (SBP) ≥110 mmHg at screening measured after at least 10 minutes of rest in the supine position, and on the dosing day prior to administration of study intervention measured after at least 1 hour of rest in the supine position.
• Resting heart rate ≥50 bpm at screening and on the dosing day prior to administration of study intervention, measured after at least 10 minutes of rest in the supine position.
• BMI within the range 18 to 32 kg/m2
• Male participants who refrain from donating sperms and either remain abstinent from sexual intercourse or agree to use protocol-required contraception.
• Female participants who are not pregnant or breastfeeding and are of non-childbearing potential, or if of childbearing potential, agree to use protocol-required contraception and not to donate ova.
• Participants able to provide signed informed consent form.
• Agree to abstain from smoking cigarettes or equivalent nicotine-containing products from 7 days prior to study drug administration through to the end of study visit.
• Willing and able to adhere to study restrictions and to be confined at the CRU.

You may not qualify if:

• History or presence of cardiovascular, respiratory including resolved childhood asthma, hepatic, renal, gastrointestinal including cholecystectomy, endocrinological, haematological, immunological, psychiatric including history of depression/anxiety or neurological disorders including migraine capable of (as judged by the PI/delegate) significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
• History of clinically significant hypersensitivity or allergic reactions (e.g. anaphylaxis, angioedema, or severe cutaneous reactions) to any drug or excipient, including components of the study intervention, or a history of multiple drug allergies, which in the opinion of the investigator would place the participant at increased risk or contraindicate participation in the study.
• Abnormal blood pressure determined clinically significant by the PI/delegate.
• Symptomatic herpes zoster within 3 months prior to screening.
• Evidence of active or latent tuberculosis (TB) as documented by medical history, and TB testing consisting of a positive (not indeterminate) TB test such as QuantiFERON-R TB Gold Plus test.
• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• Breast cancer within the past 10 years.
• QTc \> 450 msec for male participants or \> 470 msec for female participants.
• eGFR (CKD-EPI method) \<80 mL/min/1.73 m2
• Alanine transaminase (ALT) or aspartate transaminase (AST) \> 1.5 x upper limit of normal (ULN).
• Total bilirubin \> 1.5 x ULN
• Current or chronic history of liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, steatotic liver disease,autoimmune hepatitis, haemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the PI/delegate.
• Presence of hepatitis B surface antigen (HBsAg) at screening.
• Positive hepatitis C antibody test result at screening unless hepatitis C virus ribonucleic acid (HCV-RNA) negative test is documented.
• Individuals with Gilbert syndrome.

Sponsors & Collaborators

• Tes Pharma S.r.l.: lead
• Tes Pharma AU Pty Ltd: collaborator

Study Sites (1)

Novatrials

Charlestown, Suite 301, 99 Pacific Highway,NSW, 2290, Australia

RECRUITING

Central Study Contacts

Jennifer Martin

CONTACT

+6140961159; jennifer@novatrials.com.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 22, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): March 3, 2027
• Study Completion (Estimated): March 3, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)