COVID-19Phase 1NCT05872958
Dose Exploration Intramuscular/Intravenous Prophylaxis Pharmacokinetic Exposure Response Study
A Phase 1 study testing AZD3152 in people with COVID-19, run by AstraZeneca at 4 sites in United States.
Trial summary
This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular [IM] injection and Intravenous [IV] infusion). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AZD3152
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 May 2023to 20 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 male or female participants.
- Participants have suitable veins for cannulation or repeated venipuncture.
- Negative SARS-CoV-2 RT-PCR or SARS-CoV-2 rapid antigen test result at Visit 1.
- Body weight ≥ 45 kg and ≤ 110 kg and body mass index ≥ 18 and <32 kg/m2 at Screening.
- Able to complete the Follow-up Period up to Day 365 as required by the protocol.
Who cannot join
- History of any clinically important disease or disorder.
- Receipt of any immunoglobulin (either COVID-19 or non-COVID related) or blood products within 6 months prior to Day 1.
- Receipt of an EVUSHELD monoclonal antibody (mAb) against SARS-CoV-2 within last 15 months before Day 1.
- Receipt of a COVID-19 vaccine within 14 days prior to Visit 1.
- SARS-CoV-2 infection within one month prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at-home testing]).
- Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration.
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- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy,
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention. This includes any acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the Screening Period or may be rescreened once.
- Any abnormal laboratory values as described in protocol.
- Any known HIV or hepatitis B or C infection at Screening.
- History of alcohol or substance abuse that in the opinion of the Investigator might interfere with the trial conduct or completion.
- Known hypersensitivity to AZD3152.
- Previous hypersensitivity or severe adverse reaction following administration of a mAb.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Anniston, Alabama, 36207
Research Site
Cullman, Alabama, 35055
Research Site
Orlando, Florida, 32819
Research Site
Scottsdale, Arizona, 85260
About this study
Official title: A Phase I, Randomized, Safety and Pharmacokinetics Study of AZD3152 in Healthy Adults (Little DIPPER)
This is a dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular [IM] injection and Intravenous [IV] infusion).
Read the detailed description
The study will be conducted in the United States of America.
Eligible healthy participants will be randomized to receive either AZD3152 or placebo administered IM or IV, across 5 fixed-dose cohorts. Participants will receive a single dose of AZD3152/placebo.
Cohort 1: Dose X of AZD3152 or placebo, as an IM injection Cohort 2: Dose X of AZD3152 or placebo, administered IV Cohort 3: Dose Y of AZD3152 or placebo, as an IM injection Cohort 4: Dose Y of AZD3152 or placebo, administered IV Cohort 5: Dose Z of AZD3152 or placebo, administered IV
The study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period of one Day.
- A Follow-up Period of 12 months after study intervention (Day 365).
- Conditions
- COVID-19
- Being tested
- AZD3152, Placebo
- Keywords
- Coronavirus disease 2019 (COVID-19), Prophylaxis setting
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3152Drug
AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms.
PlaceboOther
Placebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms.
| Study group | Role | What they receive |
|---|---|---|
| AZD3152 Dose X (IM) | Experimental | Participants will receive dose X of AZD3152 on Day 1 as a single IM injection. Receives: Drug: AZD3152 |
| AZD3152 Dose X (IV) | Experimental | Participants will receive dose X of AZD3152 on Day 1 as an IV infusion. Receives: Drug: AZD3152 |
| AZD3152 Dose Y (IM) | Experimental | Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections. Receives: Drug: AZD3152 |
| AZD3152 Dose Y (IV) | Experimental | Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion. Receives: Drug: AZD3152 |
| AZD3152 Dose Z (IV) | Experimental | Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion. Receives: Drug: AZD3152 |
| Pooled placebo | Placebo comparator | Participant will receive placebo on Day 1 either via IM injection or IV infusion. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Measured: Until Day 91
Number of participants with serious adverse event
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Measured: Until Day 365 or early discontinuation visit (EDV [approximately 19 months])
Number of participants with adverse event of special interest
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Measured: Until Day 365 or EDV (approximately 19 months)
Serum concentration of AZD3152
Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Maximum observed concentration (Cmax) of AZD3152
PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Time to reach maximum observed concentration (tmax) of AZD3152
PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Terminal elimination half-life (t1/2) of AZD3152
PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Area under the serum concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD3152
PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152
PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Apparent total body clearance (CL/F) of AZD3152 (IM administration only)
PK (CL/F) characterization of AZD3152 in serum after a single IM.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)
PK (Vz/F) characterization of AZD3152 in serum after a single IM.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Total body clearance (CL) of AZD3152 (IV administration only)
PK (CL) characterization of AZD3152 in serum after a single IV.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Volume of distribution based on terminal phase (Vz) of AZD3152 (IV administration only)
PK (Vz) characterization of AZD3152 in serum after a single IV.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Volume of distribution at steady state (Vss) of AZD3152 (IV administration only)
PK (Vss) characterization of AZD3152 in serum after a single IV.
Measured: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Secondary outcomes (1)
Number of participants with anti-drug antibody (ADA) to AZD3152
Evaluation of ADA responses to AZD3152.
Measured: Pre-dose, Days 15, 31, 91, 181, and Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start19 May 2023
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872958
- Sponsor's protocol ID
- D7000C00004
- Status last verified
- Jun 2025
- First submitted
- 15 May 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Zhang H, Clegg L, Matthews S, Chang Y, Aksyuk AA, Francisco D, Ghosh S, Soboleva K, Puri A, Ramesh M, Gibbs M, Chang LJ, Cohen TS. Safety, Pharmacokinetics, and Predicted Neutralizing Activity of the SARS-CoV-2 Monoclonal Antibody Sipavibart: Results from Little DIPPER and the SUPERNOVA Substudy. Infect Dis Ther. 2026 Sep 7. doi: 10.1007/s40121-026-01423-3. Online ahead of print.
PubMed 42704596
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Safety and Pharmacokinetics Study of AZD3152 in Healthy Adults (Little DIPPER)
- ClinicalTrials.gov ID
- NCT05872958
- Acronym / sponsor ID
- D7000C00004
- Conditions
- COVID-19
- Keywords
- Coronavirus disease 2019 (COVID-19), Prophylaxis setting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 May 2023 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 24 May 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 dose exploration study to evaluate the safety and pharmacokinetics (PK) of AZD3152 in healthy adult male and female participants, across different dose levels and routes of administration (ie, Intramuscular [IM] injection and Intravenous [IV] infusion).
Detailed description
The study will be conducted in the United States of America.
Eligible healthy participants will be randomized to receive either AZD3152 or placebo administered IM or IV, across 5 fixed-dose cohorts. Participants will receive a single dose of AZD3152/placebo.
Cohort 1: Dose X of AZD3152 or placebo, as an IM injection Cohort 2: Dose X of AZD3152 or placebo, administered IV Cohort 3: Dose Y of AZD3152 or placebo, as an IM injection Cohort 4: Dose Y of AZD3152 or placebo, administered IV Cohort 5: Dose Z of AZD3152 or placebo, administered IV
The study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period of one Day.
- A Follow-up Period of 12 months after study intervention (Day 365).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AZD3152 Dose X (IM) | Experimental | Drug: AZD3152Participants will receive dose X of AZD3152 on Day 1 as a single IM injection. |
| AZD3152 Dose X (IV) | Experimental | Drug: AZD3152Participants will receive dose X of AZD3152 on Day 1 as an IV infusion. |
| AZD3152 Dose Y (IM) | Experimental | Drug: AZD3152Participants will receive dose Y of AZD3152 on Day 1 as 2 sequential IM injections. |
| AZD3152 Dose Y (IV) | Experimental | Drug: AZD3152Participants will receive dose Y of AZD3152 on Day 1 as an IV infusion. |
| AZD3152 Dose Z (IV) | Experimental | Drug: AZD3152Participants will receive dose Z of AZD3152 on Day 1 as an IV infusion. |
| Pooled placebo | Placebo comparator | Other: PlaceboParticipant will receive placebo on Day 1 either via IM injection or IV infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male or female participants.
- Participants have suitable veins for cannulation or repeated venipuncture.
- Negative SARS-CoV-2 RT-PCR or SARS-CoV-2 rapid antigen test result at Visit 1.
- Body weight ≥ 45 kg and ≤ 110 kg and body mass index ≥ 18 and <32 kg/m2 at Screening.
- Able to complete the Follow-up Period up to Day 365 as required by the protocol.
Key exclusion criteria (13 listed)
- History of any clinically important disease or disorder.
- Receipt of any immunoglobulin (either COVID-19 or non-COVID related) or blood products within 6 months prior to Day 1.
- Receipt of an EVUSHELD monoclonal antibody (mAb) against SARS-CoV-2 within last 15 months before Day 1.
- Receipt of a COVID-19 vaccine within 14 days prior to Visit 1.
- SARS-CoV-2 infection within one month prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at-home testing]).
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 |
|---|---|---|
| AZD3152AZD3152 will be administered via IM injection or IV infusion, as per the assigned arms. | Drug | AZD3152 Dose X (IM), AZD3152 Dose X (IV), AZD3152 Dose Y (IM), AZD3152 Dose Y (IV), AZD3152 Dose Z (IV) |
| PlaceboPlacebo is a matching volume of 0.9% sodium chloride, will be administered via IM injection or IV infusion, as per the assigned arms. | Other | Pooled placebo |
Primary outcome
Number of participants with adverse event
Time frame: Until Day 91
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Number of participants with serious adverse event
Time frame: Until Day 365 or early discontinuation visit (EDV [approximately 19 months])
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Number of participants with adverse event of special interest
Time frame: Until Day 365 or EDV (approximately 19 months)
Evaluation of the safety of IM or IV administration of AZD3152 will be done.
Serum concentration of AZD3152
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
Pharmacokinetics (PK) characterization of AZD3152 in serum after a single IM or IV dose.
Maximum observed concentration (Cmax) of AZD3152
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (Cmax) characterization of AZD3152 in serum after a single IM or IV dose.
Time to reach maximum observed concentration (tmax) of AZD3152
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (tmax) characterization of AZD3152 in serum after a single IM or IV dose.
Terminal elimination half-life (t1/2) of AZD3152
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (t1/2) characterization of AZD3152 in serum after a single IM or IV dose.
Area under the serum concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD3152
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (AUClast) characterization of AZD3152 in serum after a single IM or IV dose.
Area under concentration-time curve from 0 to infinity (AUCinf) of AZD3152
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (AUCinf) characterization of AZD3152 in serum after a single IM or IV dose.
Apparent total body clearance (CL/F) of AZD3152 (IM administration only)
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (CL/F) characterization of AZD3152 in serum after a single IM.
Apparent volume of distribution based on terminal phase (Vz/F) of AZD3152 (IM administration only)
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (Vz/F) characterization of AZD3152 in serum after a single IM.
Total body clearance (CL) of AZD3152 (IV administration only)
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (CL) characterization of AZD3152 in serum after a single IV.
Volume of distribution based on terminal phase (Vz) of AZD3152 (IV administration only)
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (Vz) characterization of AZD3152 in serum after a single IV.
Volume of distribution at steady state (Vss) of AZD3152 (IV administration only)
Time frame: Pre-dose, and Day 1 until Day 365 or EDV (approximately 19 months)
PK (Vss) characterization of AZD3152 in serum after a single IV.
1 secondary outcome
Number of participants with anti-drug antibody (ADA) to AZD3152
Time frame: Pre-dose, Days 15, 31, 91, 181, and Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 42704596Zhang H, Clegg L, Matthews S, Chang Y, Aksyuk AA, Francisco D, Ghosh S, Soboleva K, Puri A, Ramesh M, Gibbs M, Chang LJ, Cohen TS. Safety, Pharmacokinetics, and Predicted Neutralizing Activity of the SARS-CoV-2 Monoclonal Antibody Sipavibart: Results from Little DIPPER and the SUPERNOVA Substudy. Infect Dis Ther. 2026 Sep 7. doi: 10.1007/s40121-026-01423-3. Online ahead of print.
- Redated CSR SynopsisLink provided by the sponsor.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3152 in people with COVID-19, run by AstraZeneca at 4 sites 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 13 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse event (time frame: Until Day 91). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872958, which also lists 1 linked publication.
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 6 Jun 2025.