Antiviral DrugPhase 1NCT07595458
Phase 1 Study on the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults
A Phase 1 study testing JST-018 combination of 3 monoclonal antibodies in people with Antiviral Drug, run by Just-Evotec Biologics at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a single dose of the study drug, JST-018, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Antiviral Drug
- What is being tested?
- JST-018 combination of 3 monoclonal antibodies
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to 4 Oct 2027
- 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
- Healthy men or women 18 to 55 years of age
- BMI between 18 and 32 kg/m2
- Negative serum pregnancy test
- Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence
- In good general health as determined by medical history, exams and tests
Who cannot join
- Acute illness or fever (≥100.4°F) within 7 days prior to dosing
- Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against smallpox, monkeypox, or other orthopox viruses.
- Receipt of any vaccine within 30 days prior to Screening, planned receipt of any vaccine prior to Day 1, or planned receipt of any vaccines before 45 days post-injection.
- Any medical condition for which IM injections would be contraindicated in the opinion of the investigator (eg, bleeding disorders, anticoagulant therapy, and severe thrombocytopenia)
- History of congenital or acquired immunodeficiency syndrome, , including positive human immunodeficiency virus (HIV-1/-2) antibody result
- Prior solid organ or bone marrow transplant
Show all 35Show fewer
- Clinically significant corneal or lens abnormality as determined by history, clinical examination, or diagnostic imaging. Including, but not limited to:
- Corrected vision of less (worse) than 20/40
- History of any clinically significant history of eye trauma, in the opinion of the investigator
- History of cataracts or current cataracts
- Lens opacity greater than NC2, C2, or P0 as determined by the Lens Opacities Classification System (LOCS) III
- History of uveitis (including acute)
- Use of ocular or inhaled prescription steroids within 1 year prior to Screening nasal steroids are permissible). A single short course (ie, less than 14 days) of systemic steroid therapy is allowed provided it is concluded more than 6 months prior to Screening.
- History of diabetes
- Use of immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior to Screening. Nasal steroid use is permissible.
- Upper arms and thighs are with insufficient muscular tissue for IM injections or is obscured by tattoos or rash
- Use of any medications started within 30 days prior to Day -1, including prescription medications, nutritional supplements, and over-the-counter medications
- Vitamin supplements are allowed
- Recommended doses of acetaminophen are allowed, except for 24 hours prior to dosing
- Recommended doses of non-steroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen) are also allowed, except for 7 days prior to dosing
- Positive hepatitis B surface antigen, hepatitis B core antigen, or hepatitis C antibody
- Positive urine drug test or cotinine (indicating active current smoking) at Screening or Day -1, positive alcohol breath test at Screening or on Day -1, or suspected/known drug abuse and/or alcohol use disorder
- Smoking or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 3 months before study drug dosing
- Dosing in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) of receiving the investigational drug prior to Screening
- Progressive, unstable, or uncontrolled medical conditions that have required medical attention or changes to medication for medical reasons within 90 days prior to consent
- History of allergic reactions or hypersensitivity reactions to other therapeutic antibodies or immunoglobulins
- Receipt of any mAbs in the 12 months prior to Screening
- High blood pressure
- Women who are either pregnant or breast-feeding
- Vulnerable individuals (eg, military recruits, persons in compulsory detention, those with limited legal capacity)
- Receipt of immunoglobulins or any blood products within 90 days prior to consent or planned receipt during the study period
- Donation or loss of >500 mL of blood within 30 days or plasma within 7 days of Day 1; any planned donation of blood or plasma during the study period
- History of any malignant neoplasm within the last 5 years, with the exception of adequately treated localized or in situ non-melanoma carcinoma of the skin or the cervix
- Strenuous activity or contact sports within 48 hours before study drug dosing and through Day 8
- 26. History of relevant drug and/or food allergies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
PPD Las Vegas Clinical Research Unit
Las Vegas, Nevada, 89113
(877) 362-2608
About this study
Official title: Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-018, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55. The main questions it aims to answer are:
- Is a single administration of JST-018 safe?
- What is the concentration of the JST-018 in the blood over time?
- Do antibodies to JST-018 develop following a dose of JST-018? Researchers will compare JST-018 to Placebo to see if there are any differences in the safety and tolerability of a single dose at different dose levels.
Read more
Participants will be confined to the clinic for the first 3 days. They will receive an injection on the second day, and then return for 9 more visits over the period of 1 year for:
- Physical exam with vital signs
- Electro-cardiogram (ECG)
- Bood collection for clinical labs and research samples
- Urine sample
- Assessment of potential adverse effects and medications taken
Read the detailed description
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to assess the safety, tolerability, and PK of a single dose of JST-018 administered IM to healthy participants.
The study will be comprised of a minimum of 3 cohorts (Cohorts A, B, and C, with 12 participants per cohort), each evaluating a single dose of JST-018 administered IM. In each cohort, 2 sentinel participants will be randomized 1:1 such that one participant receives JST-018 and 1 participant receives placebo. Following a favorable blinded safety review committee (SRC) review of sentinel safety data collected through Day 8, the remainder of the cohort (10 non-sentinel participants) will be randomized 4:1 to JST-018 or placebo, and will be dosed.
All safety data for all participants in the current cohort through Day 8 will be reviewed by the SRC in a blinded fashion for each dose cohort before escalating to the next dose cohort (for escalation from Cohort A to Cohort B and escalation from Cohort B to Cohort C); A recommendation on whether to implement Cohort D (along with a recommended dose of JST-018 to be evaluated in Cohort D) may be provided by the SRC following review of blinded safety data from Cohorts A, B, and C.
- Conditions
- Antiviral Drug
- Being tested
- JST-018 combination of 3 monoclonal antibodies, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JST-018 combination of 3 monoclonal antibodiesBiological
Monoclonal antibodies
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| JST-018 Investigational Product | Active comparator | Not described Receives: Biological: JST-018 combination of 3 monoclonal antibodies |
| JST-017 Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of of JST-018 administered intramuscularly (IM)
Incidence of solicited local (injection site) and systemic AEs post-injection through Day 7 (with the inpatient and outpatient participant diaries being collected on Day 3 and Day 8, respectively)
Measured: From injection to Day 7
Safety and tolerability of of JST-018 administered IM
Incidence of unsolicited AEs through end of study (EOS)
Measured: From injection to final visit at Week 48
Safety and tolerability of of JST-018 administered IM
Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs)
Measured: From injection to final visit at Week 48
Safety and tolerability of of JST-018 administered IM
Incidence of Clinically Significant Changes in Laboratory Values
Measured: From injection to final visit at Week 48
Safety and tolerability of JST-018 administered as IM
Incidence of Clinically Significant Changes in Vital Sign Measurements
Measured: From injection to final visit at Week 48
Safety and tolerability of JST-018 administered as IM
Incidence of Clinically Significant Changes in ECG results
Measured: From injection to final visit at Week 48
Secondary outcomes (10)
Pharmacokinetic Cmax of JST-018
Maximum observed concentration (Cmax)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-018
Time to reach maximum observed concentration (Tmax)
Measured: Time Frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-018
The timepoint with the last quantifiable concentration (Tlast)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-t of JST-018
Area under the concentration versus time curve (AUC) from time 0 to the timepoint with the last quantifiable concentration (AUC0-t)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-inf of JST-018
AUC from time 0 extrapolated to infinity (AUC0-inf)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic t1/2 of JST-018
Terminal elimination half-life (t1/2)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic CL/F of JST-018
Apparent clearance after IM administration (CL/F)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic Vz/F of JST-018
Apparent volume of distribution after IM administration (Vz/F)
Measured: From enrollment to the end of study at 48 weeks
Evaluation the effect of anti-drug antibodies (ADA)
Effect of ADAs on pharmacokinetics of JST-018
Measured: From enrollment to the end of study at 48 weeks
Evaluate if and to what extent ADAs develop following a single dose of JST-018
Proportion of participants with pre-existing ADAs and those who develop ADAs (treatment boosted and treatment induced) to JST-018
Measured: From enrollment to the end of study at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start23 Jun 2026
- Primary completion9 Nov 2026 (estimated)
- Study completion4 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiviral DrugStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blinded, Placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Just-Evotec Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595458
- Sponsor's protocol ID
- DDF4-CL101
- Other IDs
- MCDC No. W15QKN-16-9-1002
- Status last verified
- Aug 2026
- First submitted
- 7 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a study in healthy volunteers. Individual participant data is not meaningful.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of JST-018 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07595458
- Acronym / sponsor ID
- DDF4-CL101
- Conditions
- Antiviral Drug
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Just-Evotec BiologicsIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 9 Nov 2026 (estimated)
- Study completion
- 4 Oct 2027 (estimated)
- First posted
- 19 May 2026 (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.
The goal of this clinical trial is to learn if a single dose of the study drug, JST-018, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55. The main questions it aims to answer are:
- Is a single administration of JST-018 safe?
- What is the concentration of the JST-018 in the blood over time?
- Do antibodies to JST-018 develop following a dose of JST-018? Researchers will compare JST-018 to Placebo to see if there are any differences in the safety and tolerability of a single dose at different dose levels.
Participants will be confined to the clinic for the first 3 days. They will receive an injection on the second day, and then return for 9 more visits over the period of 1 year for:
- Physical exam with vital signs
- Electro-cardiogram (ECG)
- Bood collection for clinical labs and research samples
- Urine sample
- Assessment of potential adverse effects and medications taken
Detailed description
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to assess the safety, tolerability, and PK of a single dose of JST-018 administered IM to healthy participants.
The study will be comprised of a minimum of 3 cohorts (Cohorts A, B, and C, with 12 participants per cohort), each evaluating a single dose of JST-018 administered IM. In each cohort, 2 sentinel participants will be randomized 1:1 such that one participant receives JST-018 and 1 participant receives placebo. Following a favorable blinded safety review committee (SRC) review of sentinel safety data collected through Day 8, the remainder of the cohort (10 non-sentinel participants) will be randomized 4:1 to JST-018 or placebo, and will be dosed.
All safety data for all participants in the current cohort through Day 8 will be reviewed by the SRC in a blinded fashion for each dose cohort before escalating to the next dose cohort (for escalation from Cohort A to Cohort B and escalation from Cohort B to Cohort C); A recommendation on whether to implement Cohort D (along with a recommended dose of JST-018 to be evaluated in Cohort D) may be provided by the SRC following review of blinded safety data from Cohorts A, B, and C.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blinded, Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| JST-018 Investigational Product | Active comparator | Biological: JST-018 combination of 3 monoclonal antibodies |
| JST-017 Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men or women 18 to 55 years of age
- BMI between 18 and 32 kg/m2
- Negative serum pregnancy test
- Use of highly effective birth control method(s) for a minimum of 60 days prior to consent and is willing to continue use for at least 12 months, or abstinence
- In good general health as determined by medical history, exams and tests
Key exclusion criteria (35 listed)
- Acute illness or fever (≥100.4°F) within 7 days prior to dosing
- Any history of receiving treatment, vaccine, or monoclonal antibodies (mAbs) against smallpox, monkeypox, or other orthopox viruses.
- Receipt of any vaccine within 30 days prior to Screening, planned receipt of any vaccine prior to Day 1, or planned receipt of any vaccines before 45 days post-injection.
- Any medical condition for which IM injections would be contraindicated in the opinion of the investigator (eg, bleeding disorders, anticoagulant therapy, and severe thrombocytopenia)
- History of congenital or acquired immunodeficiency syndrome, , including positive human immunodeficiency virus (HIV-1/-2) antibody result
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 |
|---|---|---|
| JST-018 combination of 3 monoclonal antibodiesMonoclonal antibodies | Biological | JST-018 Investigational Product |
| PlaceboPlacebo Comparator | Drug | JST-017 Placebo |
Primary outcome
Safety and tolerability of of JST-018 administered intramuscularly (IM)
Time frame: From injection to Day 7
Incidence of solicited local (injection site) and systemic AEs post-injection through Day 7 (with the inpatient and outpatient participant diaries being collected on Day 3 and Day 8, respectively)
Safety and tolerability of of JST-018 administered IM
Time frame: From injection to final visit at Week 48
Incidence of unsolicited AEs through end of study (EOS)
Safety and tolerability of of JST-018 administered IM
Time frame: From injection to final visit at Week 48
Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs)
Safety and tolerability of of JST-018 administered IM
Time frame: From injection to final visit at Week 48
Incidence of Clinically Significant Changes in Laboratory Values
Safety and tolerability of JST-018 administered as IM
Time frame: From injection to final visit at Week 48
Incidence of Clinically Significant Changes in Vital Sign Measurements
Safety and tolerability of JST-018 administered as IM
Time frame: From injection to final visit at Week 48
Incidence of Clinically Significant Changes in ECG results
10 secondary outcomes
Pharmacokinetic Cmax of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-018
Time frame: Time Frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-t of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-inf of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic t1/2 of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic CL/F of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Vz/F of JST-018
Time frame: From enrollment to the end of study at 48 weeks
Evaluation the effect of anti-drug antibodies (ADA)
Time frame: From enrollment to the end of study at 48 weeks
Evaluate if and to what extent ADAs develop following a single dose of JST-018
Time frame: From enrollment to the end of study at 48 weeks
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 5 Aug 2026.
- Individual participant dataSharing planned: No. This is a study in healthy volunteers. Individual participant data is not meaningful.
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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.
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 JST-018 combination of 3 monoclonal antibodies in people with Antiviral Drug, run by Just-Evotec Biologics at 1 site in United States.
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 5 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 5 Aug 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 United States. 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?
Contact Nels Royer ((206)651-5094, jeb.clinicaltrials@evotec.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of of JST-018 administered intramuscularly (IM) (time frame: From injection to Day 7). The study lists 6 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 5 Aug 2026.