Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy AdultsPhase 1NCT06943378
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
A Phase 1 study testing Monoclonal antibody JST-010 in people with Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults, 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-010, 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
- Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
- What is being tested?
- Monoclonal antibody JST-010
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to 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 the Yersinia pestis bacterium
- 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
- Prior solid organ or bone marrow transplant
Show all 29Show fewer
- Use of systemic steroids, immunosuppressive agents, anticoagulants, or antiarrhythmics within 1 year prior. A single short course (ie, less than 14 days) is allowed provided it is concluded more than 6 months prior to Screening
- Upper arm is with insufficient muscular tissue for IM injections or is obscured by tattoos or rash that may preclude accurate assessment of injection site reactions
- 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 human immunodeficiency virus (HIV-1/-2) antibody result by history or at Screening
- 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
- History of hyperprolinemia
- 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
- History of relevant drug and/or food allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Las Vegas Clinical Research Unit
Las Vegas, Nevada, 89113
About this study
Official title: Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Dose Expansion Study to Assess the Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody, JST-010, in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, 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 injection of JST-010 safe?
- What is the concentration of the JST-01 in the blood over time?
- Do antibodies to JST-010 develop following a dose of JST-010?
Read more
Researchers will compare JST-010 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
Read the detailed description
This is a two-part, Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) (Part 1) and dose expansion (Part 2) study to assess the safety, tolerability, and PK of a single dose of JST-010 administered IM to healthy participants.
Part 1 will comprise a minimum of 3 SAD cohorts (Cohorts A, B, and C, with 14 participants per cohort), each evaluating a single dose of JST-010 administered IM. In each SAD cohort, 2 sentinel participants will be randomized 1:1 such that one participant receives JST-010 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 (12 non-sentinel participants) will be randomized 5:1 to JST-010 or placebo, and the first block of 6 participants (5:1 JST-010 to placebo) will be dosed. The SRC will review the safety data collected during the first 48 hours after dosing for the first block of 6 participants dosed to determine whether the second block of 6 participants can be dosed.
All safety data for all participants in the current cohort through Day 8 with cumulative prior safety data 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); the SRC will have the ability to consult with the independent data monitoring committee (IDMC) as needed regarding these decisions. A recommendation on whether to implement Cohort D (along with a recommended dose of JST-010 to be evaluated in Cohort D) may be provided by the SRC following review of blinded safety data from Cohorts A, B, and C, or may be provided by the IDMC following review of unblinded safety, PK, and antidrug antibody (ADA) data from Cohorts A, B, and C.
- Being tested
- Monoclonal antibody JST-010, Placebo
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal antibody JST-010Biological
Active study drug
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| JST-010: The active investigational product | Active comparator | Not described Receives: Biological: Monoclonal antibody JST-010 |
| JST-012 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 a single dose of JST-010 when administered intramuscularly (IM) in healthy adults
- 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).
- Incidence of unsolicited AEs through end of study (EOS).
- Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs) post-injection through EOS.
Measured: 1) Local and systemic solicited AES from injection to Day 7, 2) All AEs post-injection to final visit at Week 48, 3) SAEs, MAAEs, and AESIs post-injection to final visit at Week 48
Secondary outcomes (10)
Pharmacokinetic Cmax of JST-010
Maximum observed concentration (Cmax)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-010
Time to reach maximum observed concentration (Tmax)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-010
The timepoint with the last quantifiable concentration (Tlast)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-D85 of JST-010
Area under the concentration versus time curve (AUC) from time 0 to Day 85 (AUC0-D85)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-t of JST-010
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-010
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-010
Terminal elimination half-life (t1/2)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic CL/F of JST-010
Apparent clearance after IM administration (CL/F)
Measured: From enrollment to the end of study at 48 weeks
Pharmacokinetic Vz/F of JST-010
Apparent volume of distribution after IM administration (Vz/F)
Measured: From enrollment to the end of study at 48 weeks
Evaluation of anti-JST-010 drug antibodies following IM administration of a single dose of JST-010
Immunogenicity: ADAs that develop to JST-010 or are pre-existing prior to administration of JST-010 may be associated with potential allergic reactions and could negatively impact the effectiveness of JST-010. ADAs will be evaluated throughout the duration of the trial. Participants who develop any AE associated with the development of ADAs will be followed until such AEs are resolved, stable, or judged by the investigator to be not clinically significant.
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 posted24 Apr 2025
- Study start16 May 2025
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy AdultsStudies 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
- 104 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
- NCT06943378
- Sponsor's protocol ID
- DDF3-CL101
- Other IDs
- MCDC No. W15QKN-16-9-1002
- Status last verified
- May 2026
- First submitted
- 9 Apr 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 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 and Dose Expansion Study to Assess the Safety, Tolerability and Pharmacokinetics of a Monoclonal Antibody, JST-010, in Healthy Adults
- ClinicalTrials.gov ID
- NCT06943378
- Acronym / sponsor ID
- DDF3-CL101
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Just-Evotec BiologicsIndustry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Apr 2025 (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-010, 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 injection of JST-010 safe?
- What is the concentration of the JST-01 in the blood over time?
- Do antibodies to JST-010 develop following a dose of JST-010?
Researchers will compare JST-010 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 two-part, Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD) (Part 1) and dose expansion (Part 2) study to assess the safety, tolerability, and PK of a single dose of JST-010 administered IM to healthy participants.
Part 1 will comprise a minimum of 3 SAD cohorts (Cohorts A, B, and C, with 14 participants per cohort), each evaluating a single dose of JST-010 administered IM. In each SAD cohort, 2 sentinel participants will be randomized 1:1 such that one participant receives JST-010 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 (12 non-sentinel participants) will be randomized 5:1 to JST-010 or placebo, and the first block of 6 participants (5:1 JST-010 to placebo) will be dosed. The SRC will review the safety data collected during the first 48 hours after dosing for the first block of 6 participants dosed to determine whether the second block of 6 participants can be dosed.
All safety data for all participants in the current cohort through Day 8 with cumulative prior safety data 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); the SRC will have the ability to consult with the independent data monitoring committee (IDMC) as needed regarding these decisions. A recommendation on whether to implement Cohort D (along with a recommended dose of JST-010 to be evaluated in Cohort D) may be provided by the SRC following review of blinded safety data from Cohorts A, B, and C, or may be provided by the IDMC following review of unblinded safety, PK, and antidrug antibody (ADA) 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-010: The active investigational product | Active comparator | Biological: Monoclonal antibody JST-010 |
| JST-012 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 (29 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 the Yersinia pestis bacterium
- 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
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 |
|---|---|---|
| Monoclonal antibody JST-010Active study drug | Biological | JST-010: The active investigational product |
| PlaceboPlacebo | Drug | JST-012 Placebo |
Primary outcome
Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults
Time frame: 1) Local and systemic solicited AES from injection to Day 7, 2) All AEs post-injection to final visit at Week 48, 3) SAEs, MAAEs, and AESIs post-injection to final visit at Week 48
1. 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). 2. Incidence of unsolicited AEs through end of study (EOS). 3. Incidence of SAEs, medically attended AEs (MAAEs), and AEs of special interest (AESIs) post-injection through EOS.
10 secondary outcomes
Pharmacokinetic Cmax of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tmax of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Tlast of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-D85 of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-t of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic AUC0-inf of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic t1/2 of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic CL/F of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Pharmacokinetic Vz/F of JST-010
Time frame: From enrollment to the end of study at 48 weeks
Evaluation of anti-JST-010 drug antibodies following IM administration of a single dose of JST-010
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 12 May 2026.
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 Monoclonal antibody JST-010 in people with Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults, 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 29 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 12 May 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?
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?
Safety and tolerability of a single dose of JST-010 when administered intramuscularly (IM) in healthy adults (time frame: 1) Local and systemic solicited AES from injection to Day 7, 2) All AEs post-injection to final visit at Week 48, 3) SAEs, MAAEs, and AESIs post-injection to final visit at Week 48). 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 12 May 2026.