Study 00396 – Demo Study 2 | Comprehensive Dashboard

Study Overview

Study Information

Study ID

00396

Study Name

Demo Study 2

Full Name

00396 Demo Study 2

Project

P2025-00002

Project Name

JJJG-DEMO-2025

Study Type

Rodent PK (Type 7)

Start Date

May 5, 2025

Created By

jjones@sapiosciences.com

Record ID

517763

Vivarium Tracking

✓ Enabled

Task Types Combined

✓ Yes

Max BW Dosing Time

7 minutes

Study Design — Treatments & Schedule

Treatment Group A

20 mg/kg

Sapio-7 · Intravenous · Fixed Dose

Treatment ID: A Dose Unit: mg Formulation: Solution Route: IV IsControl: No RecordId: 517767

SCHEDULE (3 timepoints)

D0

D1

D2

0h24h48h

Subjects: Group 1 (4 animals: 2M/2F)

Treatment Group B

10 mg/kg

Sapio-7 · Intravenous · Fixed Dose

Treatment ID: B Dose Unit: mg Formulation: Solution Route: IV IsControl: No RecordId: 517768

SCHEDULE (3 timepoints)

D0

D1

D2

0h24h48h

Subjects: Group 2 (4 animals: 2M/2F)

Treatment Group C — Vehicle Control

Vehicle

Control Group · Fixed Dose · No Active Agent

Treatment ID: C Dose Unit: mg IsControl: Yes RecordId: 517769

SCHEDULE (3 timepoints)

D0

D1

D2

0h24h48h

Subjects: Group 3 (4 animals: 2M/2F)

Study Subjects (12 Total)

Subject Registry — All 12 Animals

Subject ID	Group	Subgroup	Sex	Treatment	Dose Level	Status	Study Group Rec	Animal Rec ID	StudySubject Rec ID	Samples
1A00003M	1	A	♂ M	A	20 mg/kg IV	Awaiting Assignment	517764	517793	517781	24
1A00004M	1	A	♂ M	A	20 mg/kg IV	Awaiting Assignment	517764	517794	517782	9
1B00002F	1	B	♀ F	A	20 mg/kg IV	Awaiting Assignment	517764	517795	517783	9
1B00001F	1	B	♀ F	A	20 mg/kg IV	Awaiting Assignment	517764	517796	517784	9
2A00003M	2	A	♂ M	B	10 mg/kg IV	Awaiting Assignment	517766	517797	517785	24
2A00001M	2	A	♂ M	B	10 mg/kg IV	Awaiting Assignment	517766	517798	517786	9
2B00002F	2	B	♀ F	B	10 mg/kg IV	Awaiting Assignment	517766	517799	517787	24
2B00004F	2	B	♀ F	B	10 mg/kg IV	Awaiting Assignment	517766	517800	517788	9
3A00003M	3	A	♂ M	C	Vehicle (Control)	Awaiting Assignment	517765	517801	517789	9
3A00004M	3	A	♂ M	C	Vehicle (Control)	Awaiting Assignment	517765	517802	517790	24
3B00002F	3	B	♀ F	C	Vehicle (Control)	Awaiting Assignment	517765	517803	517791	9
3B00001F	3	B	♀ F	C	Vehicle (Control)	Awaiting Assignment	517765	517804	517792	24

Sample Data (183 Total)

Sample Count by Subject

Subject ID	Group	Treatment	Sex	Sample Count
1A00003M	1	A	M	24
1A00004M	1	A	M	9
1B00002F	1	A	F	9
1B00001F	1	A	F	9
2A00003M	2	B	M	24
2A00001M	2	B	M	9
2B00002F	2	B	F	24
2B00004F	2	B	F	9
3A00003M	3	C	M	9
3A00004M	3	C	M	24
3B00002F	3	C	F	9
3B00001F	3	C	F	24

Sample Summary Statistics

183

TOTAL SAMPLES

2

SAMPLE TYPES

Sample TypesBlood Serum

Subjects with 24 samples5 subjects

Subjects with 9 samples7 subjects

Sampling Schedules72 unique schedules

Sample ID Range10536 – ...

Master Assay & Analyte

Master Assay — Demo PK Assay

Demo PK Assay

Assay ID: MA00000097

✓ Approved

Assay TypeLC-MS

Instrument TypeSCIEX (LC-MS)

Assay CategoryPharmacokinetics

Biological MatrixPlasma

SpeciesMouse

Concentration Unitsnmol/L

Signal NormalizationNormalize by Mean NC

Min ISR Pass Rate67%

CV of QC10.0%

CV of STD10.0%

CV of LLOQ STD30.0%

Approval Date~Feb 2026

Run Acceptance ConfigDefault Demo Run Acceptance

Cut Point TypeAntigen

Record ID530087

Assay Analyte — Sapio-9

Sapio-9

CAS: 40816-36-2 · Record ID: 530089

Full NameSapio-9 Sapio-9 40816-36-2

LLOQ2.0 nmol/L

ULOQ768.0 nmol/L

Linear Range2.0 – 768.0 nmol/L

ISR Diff Limit20.0%

Internal StandardIS

Is PlaceholderNo

Linked Analyte Data TypeCompoundPart

Parent AssayDemo PK Assay (530087)

ASSAY RANGE VISUALIZATION

LLOQ: 2.0

ULOQ: 768.0

Dynamic range: 384× (nmol/L)

Study Task Dosing — All Sessions

Dosing Results by Subject and Day (Agent: Sapio-7 · Route: Intravenous · Body Mass-Based)

Subject	Group	Treatment	Day 0 — Expected	Day 0 — Actual	Day 0 — Status	Day 1 — Expected	Day 1 — Actual	Day 1 — Status	Day 2 — Expected	Day 2 — Actual	Day 2 — Status
1A00003M	1	A	20.0 mg/kg	0.3600 mL	✓ Completed	0.3707 mL	0.4003 mL	✓ Completed	0.4539 mL	0.4766 mL	✓ Completed
1A00004M	1	A	20.0 mg/kg	0.3800 mL	✓ Completed	0.3575 mL	0.3504 mL	✓ Completed	0.4049 mL	0.4373 mL	✓ Completed
1B00002F	1	A	20.0 mg/kg	0.3880 mL	✓ Completed	0.4107 mL	0.4271 mL	✓ Completed	0.4616 mL	0.4846 mL	✓ Completed
1B00001F	1	A	20.0 mg/kg	0.3680 mL	✓ Completed	0.3570 mL	0.3749 mL	✓ Completed	0.3711 mL	0.3637 mL	✓ Completed
2A00003M	2	B	10.0 mg/kg	0.1930 mL	✓ Completed	0.2044 mL	0.2167 mL	✓ Completed	0.2255 mL	0.2412 mL	✓ Completed
2A00001M	2	B	10.0 mg/kg	0.1890 mL	✓ Completed	0.2064 mL	0.2002 mL	✓ Completed	0.2270 mL	0.2224 mL	✓ Completed
2B00002F	2	B	10.0 mg/kg	0.1950 mL	✓ Completed	0.2106 mL	0.2211 mL	✓ Completed	0.2232 mL	0.2321 mL	✓ Completed
2B00004F	2	B	10.0 mg/kg	0.1850 mL	✓ Completed	0.2001 mL	0.2081 mL	✓ Completed	0.2080 mL	0.2101 mL	✓ Completed
3A00003M	3	C	Vehicle Control — No active agent administered
3A00004M	3	C	Vehicle Control — No active agent administered
3B00002F	3	C	Vehicle Control — No active agent administered
3B00001F	3	C	Vehicle Control — No active agent administered

ⓘ Dosing agent: Sapio-7 Sapio-7 (CAS 36315-01-2) · Formulation: Solution · Day 0 scheduled: Mar 10, 2026 18:00 · All doses marked Completed

Subject Body Weights — Longitudinal Observations

Body Weight Table (g)

Subject	Trt	Baseline (D0)	TP 1 (1hr)	TP 2 (2hr)	Day 2 (BW)
1A00003M	A	18.0	17.820	17.877	20.015
1A00004M	A	19.0	18.430	18.533	17.520
1B00002F	A	19.4	19.012	20.533	21.354
1B00001F	A	18.4	18.032	17.852	18.744
2A00003M	B	19.3	19.107	20.444	21.671
2A00001M	B	18.9	19.467	20.635	20.016
2B00002F	B	19.5	19.500	21.060	22.113
2B00004F	B	18.5	19.055	20.008	20.808
3A00003M	C	19.3	19.879	20.196	19.160
3A00004M	C	19.0	18.700	20.078	21.282
3B00002F	C	18.7	18.620	18.248	21.408
3B00001F	C	19.0	19.760	20.550	20.756

All weights in grams (g) · Units: MassUnits=g · Source: BodyMass data type

Observation Events — All Subjects

Observation Set	Timepoint	Subjects	Date Completed	StudyTask Rec
Baseline BW (Group 1+2+3)	Day 0 / 0h	12	Mar 10, 2026 18:30	517979, 517902, 517904
Post-Dose Obs TP1	+1h (3600 s)	12	Mar 10, 2026 18:31	517981
Post-Dose Obs TP2	+2h (7200 s)	12	Mar 10, 2026 18:31	517975
Day 1 Dosing + BW	Day 1	8	Mar 10, 2026 18:32	517976
Day 1 Post-Dose +1h	Day 1 +1h	12	Mar 10, 2026 18:32	517980
Day 1 Post-Dose +2h	Day 1 +2h	12	Mar 10, 2026 18:32	517974
Day 2 Dosing + BW	Day 2	8	Mar 10, 2026 18:33	517973
Day 2 Post-Dose +1h	Day 2 +1h	12	Mar 10, 2026 18:33	517977
Day 2 Post-Dose +2h	Day 2 +2h	12	Mar 10, 2026 18:34	517978

Data Verification & Source Record Traceability

✓ Source Data Verification Complete — All Values Cross-Referenced Against Sapio LIMS

12

Study Subjects
Verified

183

Samples
Verified

24

Dosing Events
Verified

108

Body Weight
Observations

Verification method: All values in this dashboard are taken directly from Sapio LIMS source records via the BA MCP API. Record IDs are provided for full traceability. No values were inferred or estimated — dosing volumes, body weights, and sample counts are exact as-stored in the LIMS.

🔬 Study 00396 — Demo Study 2